Scolaris Content Display Scolaris Content Display

Flow diagram illustrating selection process.
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Figure 1

Flow diagram illustrating selection process.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Topical antifungals in CRS, Outcome 1 Symptoms scores.
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Analysis 1.1

Comparison 1 Topical antifungals in CRS, Outcome 1 Symptoms scores.

Comparison 1 Topical antifungals in CRS, Outcome 2 Disease‐specific quality of life.
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Analysis 1.2

Comparison 1 Topical antifungals in CRS, Outcome 2 Disease‐specific quality of life.

Comparison 1 Topical antifungals in CRS, Outcome 3 Nasal endoscopy score.
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Analysis 1.3

Comparison 1 Topical antifungals in CRS, Outcome 3 Nasal endoscopy score.

Comparison 1 Topical antifungals in CRS, Outcome 4 Radiographic scores.
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Analysis 1.4

Comparison 1 Topical antifungals in CRS, Outcome 4 Radiographic scores.

Comparison 1 Topical antifungals in CRS, Outcome 5 Primary PROM (Patient Report Outcome Measure).
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Analysis 1.5

Comparison 1 Topical antifungals in CRS, Outcome 5 Primary PROM (Patient Report Outcome Measure).

Comparison 1 Topical antifungals in CRS, Outcome 6 Adverse drug reactions.
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Analysis 1.6

Comparison 1 Topical antifungals in CRS, Outcome 6 Adverse drug reactions.

Comparison 2 Systemic antifungals in CRS, Outcome 1 Symptom score.
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Analysis 2.1

Comparison 2 Systemic antifungals in CRS, Outcome 1 Symptom score.

Comparison 2 Systemic antifungals in CRS, Outcome 2 Radiographic scores.
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Analysis 2.2

Comparison 2 Systemic antifungals in CRS, Outcome 2 Radiographic scores.

Table 1. Adverse events

Report

Antifungal group, n (%)

Placebo group, n (%)

Complaints in total population

Comments

Topical

Ebbens 2006a

Yes

39 (66)

35 (61)

Acute exacerbation of CRS, headache, facial pain, increased congestion and/or rhinorrhoea, allergic rhinitis and/or sneezing, epistaxis, common cold, flu, cacosmia, mucocele, otitis media, otitis externa, earache and/or fullness, tinnitus, nasal irritation caused by douche, toothache, pharyngitis, asthma exacerbation, bronchitis, pneumonia, cough, dyspnoea, chest pain, dizziness, itchy eyes, eye infection, fever, reflux and/or gastric pain, fungal and/or yeast infection skin, psoriasis exacerbation, skin rash, surgery for stress incontinence, cystitis, cyst in groin, back pain, muscle ache, gout, insomnia

Quote: "The proportion of patients experiencing a serious adverse event, as judged by the investigators, was higher in the amphotericin B group than in the placebo group: 5 (9%) of 59 versus 0 (0%) of 57 respectively. There was only 1 serious adverse event reported as drug‐related (asthma attack)"

Gerlinger 2009

Yes

6 (37.5)

1 (5.9)

Short‐term nasal burning, dryness of the nasal mucus, bleeding

The therapy did not have to be interrupted because of side effects in any of the cases

Liang 2008

Yes

1 (2.9)

0 (0)

Skin itching

Information regarding adverse effects was only provided for patients that discontinued the study

Ponikau 2005a

Yes

2 (13.3)

0 (0)

Nasal burning

The 2 patients that had adverse effects discontinued the study

Weschta 2004

Yes

7 (25)

1 (0.03)

Intolerance to medication. Acute exacerbation of CRS

Information regarding adverse effects was only provided for patients that discontinued the study

Quote: "The patients in the AMB group reported nasal burning (P < 0.005) and nasal blockage (P < 0.05) more frequently than the patients in the control group. Serious adverse effects were not observed."

Summary

55 (38.5)

37 (24.5)

Systemic

Kennedy 2005

Yes

9 (36.0)

16 (57.1)

Infections, nervous system disorders, respiratory disorders, injury, eye disorders, gastrointestinal disorders, general disorders, increased AST, ALT or GGT, metabolism and nutrition disorders, pregnancy, psychiatric disorders, endocrine disorder, musculoskeletal disorders, skin and subcutaneous tissue disorders, vascular disorders

Quote: "One AE in placebo (chest pain) and one AE in terbinafine (pregnancy) were classified as serious AE, but again, neither was suspected to be related to study medication... No clinically significant difference between treatment groups was observed in liver function tests (LFT) at week 3 or week 6"

AE: adverse event
ALT: alanine transaminase
AMB: amphotericin B
AST: aspartate transaminase
CRS: chronic rhinosinusitis
GGT: gamma glutamyl transferase

Figuras y tablas -
Table 1. Adverse events
Comparison 1. Topical antifungals in CRS

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptoms scores Show forest plot

3

206

Std. Mean Difference (IV, Fixed, 95% CI)

0.35 [0.07, 0.62]

2 Disease‐specific quality of life Show forest plot

5

294

Std. Mean Difference (IV, Fixed, 95% CI)

0.18 [‐0.05, 0.42]

3 Nasal endoscopy score Show forest plot

4

233

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.00 [‐0.26, 0.26]

4 Radiographic scores Show forest plot

3

114

Std. Mean Difference (IV, Fixed, 95% CI)

0.02 [‐0.36, 0.41]

5 Primary PROM (Patient Report Outcome Measure) Show forest plot

5

294

Std. Mean Difference (IV, Fixed, 95% CI)

0.21 [‐0.02, 0.44]

6 Adverse drug reactions Show forest plot

5

294

Risk Ratio (M‐H, Random, 95% CI)

3.36 [0.86, 13.07]

Figuras y tablas -
Comparison 1. Topical antifungals in CRS
Comparison 2. Systemic antifungals in CRS

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptom score Show forest plot

1

47

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.07 [‐0.64, 0.51]

2 Radiographic scores Show forest plot

1

49

Mean Difference (IV, Fixed, 95% CI)

‐0.14 [‐19.22, 18.94]

Figuras y tablas -
Comparison 2. Systemic antifungals in CRS